Knee OsteoarthritisNCT06109220
Treatment of Knee Osteoarthritis (KOA) by Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) Into Joint Cavity
A study testing Stromal vascular fraction,SVF in people with Knee Osteoarthritis, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (SVF) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Stromal vascular fraction,SVF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The age range is 20-70 years old
- Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower
- The physical health status is mainly in the ASA grade Ⅰ, Ⅱ and Ⅲ
- Subjects had no active tumors, no active inflammation, no treponema pallidum, HIV, hepatitis B virus, or hepatitis C virus
- The subject shall provide the physical examination report of knee X-ray examination, MRI examination and other items
Who cannot join
- Patients with nonunion or displaced fractures around defective cartilage
- Pregnant or lactating women
- Autoimmune disease
- Subjects with diabetes (exceptions are patients whose blood sugar levels remain within the normal range and diabetes has not caused other complications)
- The patients had severe neurological diseases affecting the evaluation of postoperative results
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shannxi, 710034
Dawei Zhang, Doctor, +862984771012, xjchenyongfeng@163.com
About this study
Official title: Clinical Study on the Safety and Efficacy of Intrarticular Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) in the Treatment of Knee Osteoarthritis (KOA)
The purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (SVF) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution before and after SVF injection.
- Conditions
- Knee Osteoarthritis
- Being tested
- Stromal vascular fraction,SVF
- Keywords
- Stromal vascular fraction
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal vascular fraction,SVFBehavioural
SVF was injected into the knee cavity
| Study group | Role | What they receive |
|---|---|---|
| Stage of arthritis | Experimental | Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower Receives: Behavioral: Stromal vascular fraction,SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2 mapping
The degree of change of articular cartilage was observed
Measured: 24 months after the first SVF injection into the knee cavity
Secondary outcomes (1)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC is a specific assessment scale for osteoarthritis, which is assessed according to three aspects: pain, stiffness and function. A total of 24 WOMAC scores were scored, 0-10 points for each item, with a total score of 240 points. A total score <80 was mild OA, a total score of 80-120 was moderate OA, and a total score of >120 was severe OA.The severity and therapeutic effect of arthritis were evaluated according to the relevant symptoms and signs of patients.
Measured: 24 months after the first SVF injection into the knee cavity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start30 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109220
- Sponsor's protocol ID
- KY20232112-X-1
- Status last verified
- Mar 2023
- First submitted
- 18 Aug 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Intrarticular Injection of Autologous Adipose-derived Vascular Matrix Components (SVF) in the Treatment of Knee Osteoarthritis (KOA)
- ClinicalTrials.gov ID
- NCT06109220
- Acronym / sponsor ID
- KY20232112-X-1
- Conditions
- Knee Osteoarthritis
- Keywords
- Stromal vascular fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to analyze and study the efficacy and safety of autologous adipose-derived vascular matrix components (SVF) in patients with knee osteoarthritis before and after treatment through clinical evaluation, radiation index, and metabolic index comparison between plasma and irrigation solution before and after SVF injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage of arthritis | Experimental | Behavioral: Stromal vascular fraction,SVFPatients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age range is 20-70 years old
- Patients with unilateral or bilateral knee degenerative inflammation (KOA) with Kellgren-lawrence rating of level 3 or lower
- The physical health status is mainly in the ASA grade Ⅰ, Ⅱ and Ⅲ
- Subjects had no active tumors, no active inflammation, no treponema pallidum, HIV, hepatitis B virus, or hepatitis C virus
- The subject shall provide the physical examination report of knee X-ray examination, MRI examination and other items
Key exclusion criteria (5 listed)
- Patients with nonunion or displaced fractures around defective cartilage
- Pregnant or lactating women
- Autoimmune disease
- Subjects with diabetes (exceptions are patients whose blood sugar levels remain within the normal range and diabetes has not caused other complications)
- The patients had severe neurological diseases affecting the evaluation of postoperative results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stromal vascular fraction,SVFSVF was injected into the knee cavity | Behavioural | Stage of arthritis |
Primary outcome
T2 mapping
Time frame: 24 months after the first SVF injection into the knee cavity
The degree of change of articular cartilage was observed
1 secondary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 24 months after the first SVF injection into the knee cavity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stromal vascular fraction,SVF in people with Knee Osteoarthritis, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanyan Jia (+862984771794, xiyyllwyh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T2 mapping (time frame: 24 months after the first SVF injection into the knee cavity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.